NCI Central Institutional Review Board

Independent Protocol Review Model

The Central Institutional Review Board (CIRB) Initiative, sponsored by The National Cancer Institute (NCI) in consultation with the Department of Health and Human Services Office for Human Research Protections, is designed to help reduce the administrative burden on local IRBs and investigators, while maintaining a high level of protection for human research participants. The CIRB enables an investigator to enroll patients into adult and pediatric NCI-sponsored clinical trials significantly faster than if the traditional method of IRB review is employed.

The ECOG-ACRIN Cancer Research Group designs and conducts biomarker-driven clinical trials involving adults who have or are at risk of developing cancer. The majority of ECOG-ACRIN’s therapeutic trials are conducted under the sponsorship of the NCI through its Cancer Therapy Evaluation Program (CTEP), and the CIRB Initiative pertains to these trials.

In the independent protocol review model, the CIRB is the sole IRB of record and is responsible for both study review and review of local context considerations for enrolled institutions. In the facilitated protocol review model, the local IRB conducted the review. A pilot study completed in October 2012 showed that the CIRB could add the review of local context considerations to its current review of studies for participant protections without significantly adding to the burden of the institutional staff or CIRB members.

More information about the independent protocol review model can also be found at the CIRB website.

Contact

Inquiries about the use of the CIRB in ECOG-ACRIN trials may be directed to:
ECOG-ACRIN Regulatory Affairs TeamEmail